Recall Z-1209-2022 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
| Date | Mar 3, 2022 |
| Status | Completed |
| Reason | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. |
| Root cause | Use error |
| Action | On 03/03/22, a Field Safety Notice was sent via courier service to customers. In section 4, "Actions to be taken by the Customer/User" of the Field Safety Notice includes the following: Place the customer communication with the User Manual. In addition, 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the System that they should reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual b. Contacting Sales Representatives for clarification of queri |
| Quantity | 140,519 boxes (843,113 individual units) |
| Distribution | Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Leb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend Intuitive Surgical, Inc., Apr 26, 2018 |